Pemeta

Indications:Nonsquamous
Non-Small Cell Lung Cancer- Combination with Cisplatin: It is indicated in
combination with Cisplatin therapy for the initial treatment of patients with
locally advanced or metastatic nonsquamous non-small cell lung cancer.
Nonsquamous Non-Smail Cell Lung Cancer-
Combination with Carboplation & Pembrolizumab: It is indicated in
combination with Carboplation & Pembrolizumab for the initial treatment of
patients with metastatic, non-squamous NSCLC. Nonsquamous Non-Small Cell Lung Cancer- Maintenance: It is
indicated as a single agent for the maintenance treatment of patients with
locally advanced or metastatic nonsquamous non-small cell lung cancer whose
disease has not progressed after four cycles of platinum-based first-line
chemotherapy. Nonsquamous Non-Small Cell
Lung Cancer- After Prior Chemotherapy: It is indicated as a single-agent
for the treatment of patients with locally advanced or metastatic nonsquamous
non-small cell lung cancer after prior chemotherapy. Mesothelioma: It in combination with Cisplatin is indicated for the
treatment of patients with malignant pleural mesothelioma whose disease is
unresectable or who are otherwise not candidates for curative surgery.

Dosage and Administration:Recommended
Dosage and Schedule for Non-Squamous NSCLC:# The
recommended dose of Pemeta in combination with cisplatin for initial treatment
of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault
equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over
10 minutes administered prior to Cisplatin on Day 1 of each 21-day cycle for up
to six cycles in the absence of disease progression or unacceptable toxicity. # The
recommended dose of Pemeta for maintenance treatment of NSCLC in patients with
a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or
greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of
each 21-day cycle until disease progression or unacceptable toxicity after four
cycles of platinum-based first-line chemotherapy. # The
recommended dose of Pemeta for treatment of recurrent NSCLC in patients with a
creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or
greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of
each 21-day cycle until disease progression or unacceptable toxicity. Recommended Dosage and Schedule for Mesothelioma:
The recommended dose of Pemeta, administered in combination with Cisplatin, in
patients with a creatinine clearance (calculated by Cockcroft-Gault equation)
of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes
on Day 1 of each 21-day cycle until disease progression or unacceptable
toxicity. Renal Impairment: Pemeta
dosing recommendations are provided for patients with a creatinine clearance
(calculated by Cockcroft-Gault equation) of 45 mL/min or greater. There is no recommended
dose for patients whose creatinine clearance is less than 45 mL/min. Premedication and Concomitant Medications
to Mitigate Toxicity: Vitamin Supplementation:# Folic
acid should be initiated 400 mcg to 1000 mcg orally once daily, beginning 7 days
before the first dose of Pemeta and continuing until 21 days after the last
dose of Pemeta. #
Vitamin B12 should be administered, 1 mg intramuscularly, 1 week prior to the
first dose of Pemeta and every 3 cycles thereafter. Subsequent vitamin B12
injections may be given the same day as treatment with Pemeta. Corticosteroids:#
Dexamethasone should be administered 4 mg orally twice daily for three
consecutive days, beginning the day before each Pemeta administration. Or, as
directed by the registered physicians. Please see the enclosed insert.

Use in pregnancy and lactation: It can cause fetal harm when administered to a
pregnant woman. If it is used during pregnancy, or if the patient becomes pregnant
while taking this drug, the patient should be apprised of the potential hazard
to the fetus. Lactation: There is no
information regarding the presence of Pemetrexed or its metabolites in human
milk, the effects on the breastfed infant, or the effects on milk production.
Women should be advised not to breastfeed during treatment with Pemeta and for
1 week after the final dose. Pediatric
Use: The safety and effectiveness of Pemeta in pediatric patients have not
been established. Patients with Hepatic
Impairment: There was no effect of elevated AST, ALT or total bilirubin on
the pharmacokinetics of Pemetrexed. Patients
with Renal Impairment: Pemeta is primarily excreted by the kidneys.
Decreased renal function results in reduced clearance and greater exposure
(AUC) to Pemeta compared with patients with normal renal function. No dose is
recommended for patients with creatinine clearance less than 45 mL/min.